Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

This study is currently recruiting participants.
Verified March 2012 by Amylin Pharmaceuticals, LLC.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01554618
First received: March 13, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

The study examines the Safety and efficacy study of exenatide once weekly in adolescents with type 2 diabetes.


Condition Intervention Phase
Adolescent Type 2 Diabetes
Drug: Exenatide Once Weekly
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Change in HbA1c from Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment


Secondary Outcome Measures:
  • Changes in fasting plasma glucose [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment

  • Changes in body weight [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment

  • Changes in lipids [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment

  • Changes in blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EQW
Exenatide once weekly
Drug: Exenatide Once Weekly
2 mg exenatide once weekly
Other Name: BYDUREON
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c 6.5-11%
  • 10-17 years old
  • diagnosed type 2 diabetes treated with diet/exercise +/- metformin

Exclusion Criteria:

  • Type 1 diabetes
  • chronic insulin use
  • has ever used a GLP-1 receptor agonist (e.g. BYETTA, BYDUREON, or VICTOZA).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554618

Locations
Mexico
Research Site Not yet recruiting
Guadalajara, Jalisco, Mexico
Contact: Amylin Call Center    866-208-1661      
Research Site Not yet recruiting
Morelia, Michoacan, Mexico
Contact: Amylin Call Center    866-208-1661      
Research Site Not yet recruiting
Culiacan, Sinaloa, Mexico
Contact: Amylin Call Center    866-208-1661      
Reserach Site Not yet recruiting
Mexico City, Mexico
Contact: Amylin Call Center    866-208-1661      
Ukraine
Research Site Recruiting
Chernivtsi, Ukraine
Contact: Amylin Call Center    866-208-1661      
Research Site Recruiting
Donetsk, Ukraine
Contact: Amylin Call Center    866-208-1661      
Research Site Recruiting
Kiev, Ukraine
Contact: Amylin Call Center    866-208-1661      
Research Site Recruiting
Poltava, Ukraine
Contact: Amylin Call Center    866-208-1661      
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
Study Director: Senior Vice President Research and Development, M.D. Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01554618     History of Changes
Other Study ID Numbers: BCB114
Study First Received: March 13, 2012
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Mexico: Ministry of Health

Keywords provided by Amylin Pharmaceuticals, LLC.:
exenatide
diabetes
GLP-1 receptor agonist

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014